NCT02024555

Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to investigate the efficacy and safety of oral antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic pulmonary sarcoidosis participants.

Detailed description

Primary Objective: To assess the efficacy and safety of oral CLEAR therapy in patients with confirmed progressive pulmonary sarcoidosis. Hypothesis: The CLEAR regimen will improve the absolute FVC percent predicted in chronic pulmonary sarcoidosis participants by augmenting T cell responses through the normalization of p56Lck expression and IL-2 production.

Conditions

• Sarcoidosis; Antimycobacterial Therapy

Interventions

Type	Name	Description
DRUG	Levofloxacin
DRUG	Ethambutol
DRUG	Azithromycin
DRUG	Rifampin
DRUG	Placebo	This will serve as a placebo to the antibiotics used in antimycobacterial therapy.

Timeline

• Start date: 2014-03-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2013-12-31
• Last updated: 2020-07-09
• Results posted: 2020-07-09

Locations

6 sites across 1 country: United States